Non-parenteral drugs, which are found in delivery forms such as tablets, suspensions, suppositories, etc., are generally adapted to be administered to a patient via a single delivery site or administration route. For example, a chewable tablet is designed to be administered solely through the oral cavity, and its particular formulation is adapted to be delivered in that particular manner. Should a particular drug require administration through an alternate administration route, such as a suppository, which is delivered via the rectum, a different formulation including the drug will be used. There are several drawbacks which result from delivery forms of drugs which only allow administration of a particular formula to a patient via a single delivery site or administration route.
One such drawback concerns situations in which it may become difficult or impossible to administer a medication via a particular administration route. As a first example, one patient group in which this drawback may be prevalent is composed of children. Many medications are dispensed as tablets or other forms designed to be taken orally, such as suspensions. However, sick children have a propensity to become “cranky”, especially when ill, and thus become adverse to oral intake of medications. When this happens, medication may not be taken in the correct amounts, at the correct time, or taken at all, and compliance with the medicinal regimen suffers. Without proper compliance, the health of the child may worsen. This only compounds the problem in that many sick children often become even less cooperative as symptoms of the disease or sickness become more intense.
As a result of this drawback, a preparation that can be rectally administered as a suppository may allow the medicinal regimen to be followed, thus resolving the health problems of the child and resolving a potential emotionally charged family crisis by providing the medication in a delivery form that can be administered in the event that delivery via the oral route is unlikely or impossible.
However, current rectal suppositories, including pharmaceutical ingredients, are prepared in a delivery formulation that differs from the formulation used for a delivery form adapted for oral administration Thus, the oral tablet, gel, etc. cannot be administered rectally. Thus, in order to resolve the problem of the uncooperative patient, two different forms of the same medication, one oral and one rectal, need to be kept on-hand. Such a solution is impractical and generates unnecessary costs from the standpoint of the producer, who must generate pharmaceutical compositions in two separate delivery forms, and the customer, who must purchase pharmaceutical compositions in two separate delivery forms.
A second example of compliance problems may arise when the intrinsic nature of many severe health problems that commonly affect patients makes swallowing problematic. For example, gastrointestinal diseases, which involve nausea and vomiting; asthma, which involves gasping for air; seizures, which involve a change in mental status; and pharyngitis and other illnesses, which involve a severe sore throat, are examples of conditions and symptoms that oftentimes make it desirable to have a medication that is deliverable by a route other than the oral cavity. Even the most cooperative patients, those who desire to take oral medications, oftentimes cannot swallow pills, tablets, etc. when suffering from nausea and vomiting, when gasping for air from an asthma attack, when incapacitated during a seizure, or when troubled by severe sore throat.
As a third example, certain situations may require urgent or emergent delivery of medication. In such situations, it may be the case that a particular delivery form is impractical or impossible to be delivered. For example, it may be impossible to administer an oral delivery form of a composition to an incapacitated individual. Such an individual may require an alternative delivery form. In such cases, having the incorrect delivery form of a medication on hand can have grave, and possibly even fatal, consequences.
Thus, for both acutely ill patients and patients chronically dependent on medications, it is apparent that a drug delivery may be preferable via one administration route at one time, and at another time may be preferable or required via a different administration route, even as applied to the same disease and even during the same course of the same day. Thus, to eliminate the above drawbacks in current drugs and drug regimens, it would be desirable to develop a drug composition which allows for administration in different sites of a patient in order to allow a medication regimen to be complied with when one particular administration route is unavailable. Further, it would be desirable to provide a drug in a delivery form that allows one prescription to be written and filled without varying formulations. Still further, it would be desirable to allow for the prompt resolution of emergencies by providing a single delivery form which can be administered regardless of the status of the patient.